MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN? CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

Model Number	G151
Medical Device Problem Codes	Pacing Problem (1439); Failure to Convert Rhythm (1540); Defibrillation/Stimulation Problem (1573); Failure to Read Input Signal (1581); Under-Sensing (1661); Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited undersensing of ventricular arrhythmia episodes registered on the right ventricular (rv) channel.This device delivered anti-tachycardia pacing (atp) which did not convert the rhythm and no shock therapy was delivered as the device did not appropriately sense the rhythm.During one of these episodes, an atrial pace rate of 33 beats per minute (bpm) was recorded.Additionally, during stored ventricular episodes, this device displayed an isoelectric line on the right atrial (ra) channel.No adverse patient effects were reported.This crt-d remains in service.

• Brand Name: DYNAGEN? CRT-D
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24565021
• Report Number: 2124215-2026-13364
• Device Sequence Number: 21192316
• Product Code: NIK
• UDI-Device Identifier: 00802526534638
• UDI-Public: (01)00802526534638(17)190802
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/01/2019
• Device Model Number: G151
• Device Catalogue Number: G151
• Device Lot Number: 123453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 07/07/2026
• Date Device Manufactured: 08/13/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male